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Study on the Effectiveness and Safety of Early Rehabilitation After Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03938311
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
China Stroke Databank Center

Brief Summary:
There are about 2.5 million new stroke patients in China each year, and 70%-80% of stroke patients cannot live independently because of their disability. Stroke has the characteristics of high morbidity and high morbidity, which is a huge burden for families and society.The effectiveness of early rehabilitation has been confirmed, but there is a lot of debate about the best intervention time for early rehabilitation. Our study is to observe the effectiveness and safety of early rehabilitation after ischemic stroke, and to lay the foundation for establishing early rehabilitation guidelines for ischemic stroke in Chinese population.

Condition or disease Intervention/treatment Phase
Brain Ischemia Stroke Rehabilitation Other: rehabilitation Not Applicable

Detailed Description:

Objective: To observe the effectiveness and safety of early rehabilitation after ischemic stroke, and to lay the foundation for establishing early rehabilitation guidelines for ischemic stroke in Chinese population; to explore the internal rehabilitation of early ischemic stroke and brain remodeling.

Study design: a multicenter, evaluator blinded, randomized controlled clinical study

Sample size: 1500 cases

Inclusion criterias: 1 age > 18 years; 2 first or recurrent ischemic stroke, conform to the diagnostic criteria of ischemic stroke, and confirmed by CT or MRI; 3 symptoms occur within 24 hours; 4 can be oral instructions Respond; 5 vital signs are stable (systolic blood pressure is between 120-180mmHg, heart rate is between 50-100 /min, body temperature is lower than 38.5 °C, blood oxygen saturation is >92%); 6MMSE>16 points.

Exclusion criterias: 1 patients with a hemorrhagic stroke; 2 patients with a NIHSS score of less than 2; 3 patients with continuous progressing disease within the first hour after admission, presence of progressive neurological damage, acute coronary syndrome, severe heart failure, confirmed or suspected lower extremity fracture; 4 Modified Rankin scale (mRS) score of 3, 4, 5 points before stroke; 5 can not provide informed consent.

Treatment plan According to the severity of the patient's condition, the NIHSS score of 15 is divided into two levels, 2-15 points and 16-42 points. Follow-up randomization within the group: rehabilitation treatment within 24 hours after stroke (group A), rehabilitation treatment within 24 to 72 hours after stroke (group B), rehabilitation treatment started more than 72 hours after stroke (group C). According to the function evaluation of each patient, the corresponding rehabilitation treatment was arranged.

Efficacy evaluation: NIHSS score, Barthel index, modified Rankin scale, MMSE scale, imaging assessment (arterial spin labeling, diffusion tensor imaging, resting state functional MRI imaging), health economic indicators, etc.

Statistical analysis: Statistical analysis was performed with SPSS 23.0. One-way analysis of variance was used to compare statistical differences between the groups (5 time points) and between groups (3 intervention groups); the correlation between brain function imaging and clinical efficacy was explored by correlation analysis; Multivariate analysis methods such as discriminant and cluster analysis were used to explore the clinical and brain function imaging predictive indicators and thresholds that can reflect the prognosis of stroke function. Multiple regression analysis was used to analyze the factors affecting the prognosis of patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomization within the group: rehabilitation treatment within 24 hours after stroke (group A), rehabilitation treatment within 24 to 72 hours after stroke (group B), rehabilitation treatment started 72 hours after stroke (group C)
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study on the Effectiveness and Safety of Early Rehabilitation After a Ischemic Stroke
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: very early rehabilitation
rehabilitation treatment within 24 hours after stroke
Other: rehabilitation

Rehabilitation treatment is arranged based on each patient's functional assessment. Encourage patients to move out of bed as soon as possible.

Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.


Experimental: early rehabilitation
rehabilitation treatment within 24 to 72 hours after stroke
Other: rehabilitation

Rehabilitation treatment is arranged based on each patient's functional assessment. Encourage patients to move out of bed as soon as possible.

Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.


Experimental: delayed rehabilitation
rehabilitation treatment started 72 hours after stroke
Other: rehabilitation

Rehabilitation treatment is arranged based on each patient's functional assessment. Encourage patients to move out of bed as soon as possible.

Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed.





Primary Outcome Measures :
  1. NIHSS scores [ Time Frame: the total score of NIHSS will be recorded 3 months after the cerebrovascular accident/or the last time appeared normally ]
    National Institute of Health stroke scale,total scores range from 0 to 42, higher values represent a better outcome.


Secondary Outcome Measures :
  1. Barthel Index [ Time Frame: the total score of Barthel Index will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally ]
    ability of daily living, total scores range from 0 to 100, higher values represent a better outcome and independent living ability.

  2. modified Rankin Scale [ Time Frame: the degree of modified Rankin Scale will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally ]
    modified Rankin Scale, to evaluate a subject's disability status. It's a rating data. The degrees range from 0 to 5, higher values represent a worse outcome and severe disability.

  3. MMSE [ Time Frame: the total score of MMSE will be recorded 15days、1month、3 months、6months after the cerebrovascular accident/or the last time appeared normally ]
    Mini-mental State Examination. To evaluate a subject's mental state.The total score range from 0 to 30, higher values represent a better outcome.

  4. NIHSS scores [ Time Frame: the total score of NIHSS will be recorded15days、1month、6months after the cerebrovascular accident/or the last time appeared normally ]
    National Institute of Health stroke scale,total scores range from 0 to 42, higher values represent a better outcome.


Other Outcome Measures:
  1. CBF [ Time Frame: the count of CBF will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood flow

  2. CBV [ Time Frame: the count of CBV will be recorded 3months after the cerebrovascular accident/or the last time appeared normally ]
    cerebral blood volume

  3. FA [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    fractional anisotropy, a outcome of diffusion tensor imging

  4. MD [ Time Frame: 3months after the cerebrovascular accident/or the last time appeared normally ]
    mean diffusivity,a outcome of diffusion tensor imging

  5. rsFC [ Time Frame: the rsFC description will be recorded by a radiologist 3months after the cerebrovascular accident/or the last time appeared normally ]
    resting-statefunctional connectivity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 age > 18 years;
  • 2 first or recurrent ischemic stroke, conform to the diagnostic criteria of ischemic stroke, and confirmed by CT or MRI;
  • 3 symptoms occur within 24 hours;
  • 4 can be oral instructions Respond;
  • 5 vital signs are stable (systolic blood pressure is between 120-180mmHg, heart rate is between 50-100 /min, body temperature is lower than 38.5 °C, blood oxygen saturation is >92%);
  • 6MMSE>16 points.

Exclusion Criteria:

  • 1 patients with a hemorrhagic stroke;
  • 2 patients with a NIHSS score of less than 2;
  • 3 patients with continuous progressing disease within the first hour after admission, presence of progressive neurological damage, acute coronary syndrome, severe heart failure, confirmed or suspected lower extremity fracture;
  • 4 Modified Rankin scale (mRS) score of 3, 4, 5 points before stroke;
  • 5 can not provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938311


Contacts
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Contact: Xiao Lu, MD/PHD +86 025-83718836 ext 3029 luxiao1972@163.com
Contact: Chengjie Yan, master +8615995610375 jiabailie00@sina.com

Sponsors and Collaborators
China Stroke Databank Center
Investigators
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Principal Investigator: Xiao Lu, MD/PHD The First Affiliated Hospital with Nanjing Medical University

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Responsible Party: China Stroke Databank Center
ClinicalTrials.gov Identifier: NCT03938311     History of Changes
Other Study ID Numbers: GN—2018R0010
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Stroke Databank Center:
Ischemic stroke
early rehabilitation

Additional relevant MeSH terms:
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Stroke
Ischemia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes